{"product_name":"qER","company_name":"Qure.ai","product_url":"https://www.qure.ai/product/qer","company_url":"https://www.qure.ai/","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0457","summary":"qER is an AI-powered head CT scan tool developed by Qure.ai, designed to assist in the rapid detection and triage of critical brain conditions, including intracranial bleeds, mass effect, midline shift, and cranial fractures, thereby enhancing stroke and traumatic brain injury care.","description":"qER integrates seamlessly into radiology workflows, prioritizing critical cases to expedite reporting and improve patient outcomes. It has received FDA 510(k) clearance for detecting intracranial bleeds, mass effect, midline shift, and cranial fractures, and CE Class IIb certification in the European Economic Area. The tool has been deployed in numerous hospitals and teleradiology providers worldwide, processing over 8 million scans and sending more than 400,000 critical notifications. It offers features such as rapid team activation, early diagnosis support, and data-driven workflow optimization.","categories":["clinical Care","diagnostic Support","patient Facing","administrative Operations","Clinical","Diagnostic","Patient-facing","Administrative"],"market_segment":["enterprise","smb"],"target_users":["clinicians","radiologists","emergency medicine physicians","neurologists","neuro-critical care teams"],"specialties":["Neurology","Emergency Medicine","Radiology","Neuro-critical Care"],"regions_available":["United States","European Economic Area","India","Global"],"languages_supported":["English","Hindi","Spanish","French","German","Italian","Portuguese","Dutch","Swedish","Danish","Norwegian","Finnish","Polish","Czech","Hungarian","Romanian","Bulgarian","Greek","Turkish","Russian"],"pricing_model":"subscription","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["India","United States","United Kingdom","Germany","Singapore","United Arab Emirates","South Africa","Australia","Japan","China"],"company_founding":"2016","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android"],"features":["AI-powered assessment of head CT scans","Detection of intracranial hemorrhages, cranial fractures, midline shift, mass effect, infarcts, and atrophy","Rapid analysis with critical notifications to stroke teams","Integration with hospital PACS systems","Real-time communication and secure data sharing","Clinical decision support tools for treatment planning","Mobile access to imaging results","Data-driven analysis for program evaluation"],"optional_modules":["Qure App for care coordination and mobile notifications","Advanced analytics and outcomes dashboards","Enterprise integration services and custom workflow connectors"],"integrations":["PACS (DICOM-based systems)","RIS","Sectra","Philips","AWS (cloud hosting)","Medtronic (care pathway partnership)"],"data_standards":["DICOM","HL7","FHIR"],"api_available":"yes","system_requirements":"DICOM-compatible imaging source; supports cloud (AWS) or on-prem servers; integrates via standard DICOM/HL7/FHIR interfaces","compliance":["HIPAA","EU GDPR","ISO/IEC 27001","FDA 510(k)","CE IIB (MDR)"],"certifications":["FDA 510(k) clearance K200921 for qER","FDA 510(k) clearance K211222 for qER-Quant","CE IIB (MDR) clearance for qER"],"security_features":["Encryption at rest and in transit","Role-based access control (RBAC)","SSO/SAML support","Audit logging","Two-factor authentication (2FA)"],"privacy_features":["BAA available","Patient data de-identification/anonymization support","Consent/privacy policy compliance"],"data_residency":"US/EU regions","customers":["Boston Consulting Group, India"],"user_reviews":["It has the best deep learning and automated AI features to track and interpret X-rays, CTs, and Ultrasound scans within a significantly less duration of time using the best image processing and AI visions."],"ratings":["5.0 out of 5 stars on G2"],"support_channels":["email","phone","chat","ticketing","community","24x7"],"training_options":["documentation","webinars","live_online","onsite","certification"],"release_year":"2022","integration_partners":["Philips","Sectra","Medica"],"id":"SW0457","slug":"qer","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/qer.json"}}